Immunovia reports improved test performance of IMMrayTM PanCan-d in detecting early stage pancreatic cancer in high risk symptomatic patients

Rhea-AI Summary

Immunovia announced enhanced performance of its IMMray™ PanCan-d test in detecting early-stage pancreatic cancer among high-risk patients with non-specific symptoms. The clinical study demonstrated a 92% specificity and 81% sensitivity for detecting pancreatic cancers across all stages. The study analyzed 433 samples, including 202 PDACs (89 at stages I/II). The results support the commercialization strategy, targeting a potential market of 1-2 million patients in the USA and Europe. This development is pivotal for improving diagnosis and patient outcomes.

Positive

• Achieved 92% specificity and 81% sensitivity for early-stage pancreatic cancer detection.
• Study included a robust cohort of 433 samples, enhancing reliability.
• Target market consists of 1-2 million patients in the USA and Europe.

Negative

• None.

LUND, Sweden, March 30, 2021 /PRNewswire/ -- Immunovia today announced improved performance of its blood based IMMray™ PanCan-d biomarker signature together with CA 19-9, in a clinical retrospective study. The study was designed to evaluate detection of early stage pancreatic cancer in high risk patients with non-specific but concerning symptoms. The study data demonstrate that Immunovia's test  now detects pancreatic cancers (all stages) with 92% specificity and 81% sensitivity for this cohort, which is equivalent to results presented in the previous Commercial Test Model Study (link to PR). Importantly, early stage PDAC I/II were detected with specificity of 92% and sensitivity of 80%. The improved test performance was demonstrated in a combined samples cohort of newly collected samples and samples from the Clinical Verification study. In total 433 samples of which 202 were PDACs whereof 89 PDAC stage I/II and 231 symptomatic controls were analyzed. These samples have been freshly collected from 7 sites in the US and Europe: Beth Israel Deaconess Medical Center, University of Pittsburgh Medical Center, Pancreatic Cancer Center at NYU Langone's Perlmutter Cancer Center in the US; University College London in the UK; Sahlgrenska University Hospital in Sweden; and University Hospital Erlangen in Germany; and Ramón y Cajal University Hospital, IRYCIS, CIBERONC in Spain.

Linda Mellby, PhD, VP R&D Immunovia commented: "Detecting pancreatic cancer as early as possible in high risk symptomatic patients is a challenging but extremely important achievement that will support clinicians in providing accelerated and correct diagnosis to the patients. We are very excited to report 92% specificity and 80 % sensitivity for detecting early stage pancreatic cancer in this risk group of patients."

Patrik Dahlen, CEO, Immunovia added: " These results demonstrate great performance for detection of early stage pancreatic cancer in symptomatic cohorts, and they further confirm the commercialization strategy for this important risk group of patients. The market size for the symptomatic risk group is 1-2 million patients in USA and Europe. Our test is designed to help clinicians find the cancer at a treatable stage and thus help the patients live longer."

Webcasted teleconference

These results will be presented Tuesday March 30, 2021, in a webcasted teleconference at 16.30 (CET).

Presenters: Thomas King, MD, PhD, Linda Mellby, PhD, Patrik Dahlen CEO, Immunovia

The presentations will be followed by a Q&A session. The webcasted teleconference will be held in English.

Dial-in details:

SE: +46 856642651
US: +18558570686
UK: +44 3333000804
Pin code: 20761152#

Webcast: https://financialhearings.com/event/13801

Following the teleconference, a recording will be available on Immunovia's website (www.immunovia.com).

This is information that Immunovia is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 21:20 CET on March 29, 2021.

For more information, please contact:

Patrik Dahlen
CEO Immunovia
Email: patrik.dahlen@immunovia.com 
Tel: +46 73 376 76 64

About Immunovia

Immunovia AB is a diagnostic company that is developing and commercializing highly accurate blood tests for the early detection of cancer and autoimmune diseases based on Immunovia's proprietary test platform called IMMray™. Tests are based on antibody biomarker microarray analysis using advanced machine-learning and bioinformatics to single-out a set of relevant biomarkers that indicate a certain disease. Thus, forming a unique "disease biomarker signature".

The company was founded in 2007, based on cancer studies and ground-breaking research in the Department of Immuntechnology at Lund University and CREATE Health Cancer Center, Sweden.

The first product, IMMray™ PanCan-d, is undergoing clinical evaluation in some of the world's largest clinical studies for pancreatic cancer, PanFAM-1, PanSYM-1 and PanDIA-1 and is currently in the final validation phase. The company aims for a sales start at the end of Q1 2021 with subsequent commercial testing in Q2.

When validated, IMMray™ PanCan-d will be the first blood-based test for early diagnosis of pancreatic cancer on the market, with a potential to significantly improve patient survival and outcome.

Immunovia Dx Laboratories located in Marlborough, Massachusetts, USA and Lund, Sweden will provide laboratory testing services in two accredited reference laboratories.

Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/immunovia-ab/r/immunovia-reports-improved-test-performance-of-immray-tm--pancan-d-in-detecting-early-stage-pancreat,c3316650

The following files are available for download:

https://mb.cision.com/Main/13121/3316650/1394676.pdf

Press release (PDF)

View original content:http://www.prnewswire.com/news-releases/immunovia-reports-improved-test-performance-of-immraytm-pancan-d-in-detecting-early-stage-pancreatic-cancer-in-high-risk-symptomatic-patients-301258015.html

SOURCE Immunovia AB

FAQ

What were the results of the IMMray PanCan-d study reported by Immunovia on March 30, 2021?

The study reported 92% specificity and 81% sensitivity for detecting early-stage pancreatic cancer in high-risk patients.

How many samples were analyzed in the Immunovia IMMray PanCan-d study?

A total of 433 samples were analyzed, including 202 PDACs.

What is the potential market size for the IMMray PanCan-d test?

The potential market size is estimated at 1-2 million patients in the USA and Europe.

What is the significance of the test results from Immunovia's recent announcement?

The results validate the test's effectiveness, supporting its commercialization and aiding early diagnosis of pancreatic cancer.